Senior Process Engineer

Role Summary

As a Senior Process Engineer based in Carlsbad, CA, you will shape the performance, safety, and lifecycle of critical manufacturing equipment that delivers life-changing therapies to patients. You will partner with operations, automation, and quality teams to lead improvements, support new technologies, and ensure processes operate at the highest standards of excellence. This role sits at the intersection of innovation, compliance, and patient impact.

Responsibilities

• Maintain accurate master instrument and equipment inventories across the manufacturing facility.
• Provide hands-on support for installation, maintenance, troubleshooting, and repair of manufacturing assets.
• Lead and manage technical and engineering changes through the full change control lifecycle.
• Create, review, and approve engineering documentation, including procedures, plans, drawings, and specifications.
• Ensure equipment is designed, commissioned, and qualified in compliance with current Good Manufacturing Practice requirements.
• Support investigations, deviations, and corrective actions from an engineering and maintenance perspective.
• Collaborate with operations and manufacturing sciences on new product introductions and facility fit evaluations.

Qualifications

• Required: Bachelor's degree in Chemical, Electrical, or Mechanical Engineering, or a closely related technical field.
• Required: Minimum five years of engineering, maintenance, automation, or technical support experience in regulated industries.
• Required: Demonstrated ability to lead projects end-to-end, applying sound judgment to resolve complex technical challenges.
• Required: Strong knowledge of equipment troubleshooting, root cause analysis, and automated control systems.
• Required: Proven experience working in compliance with current Good Manufacturing Practice and regulatory requirements.
• Required: Effective communication and collaboration skills, with the ability to work independently and within cross-functional teams.

Skills

• Project leadership and end-to-end delivery.
• Strong troubleshooting, root cause analysis, and automated control systems knowledge.
• Experience working in regulated manufacturing environments and GMP compliance.
• Effective written and verbal communication and cross-functional collaboration.
• Hands-on installation, maintenance, and repair of manufacturing equipment.